TMF Study Lead Line Head
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The purpose of this role is to provide leadership to the Trial Master File (TMF) Study Leads staff in order to ensure TMF compliance and inspection readiness for active studies at all times. The Study Lead Line Head reports into the Global TMF Process Lead and will support that role in creating/achieving TMF Process optimization.
Supervisory responsibility for TMF Study Leads, provides training, support, and coaching as required
Oversees activities across studies to ensure compliance with TMF requirements
In collaboration with the TMF Study Leads, supports BMS audit/inspection readiness activities and consults with all relevant functions within and outside GCO to ensure readiness
Support the Global TMF Process Lead in developing Work Instructions, templates, plans and work assignments. Attend/represent the Global TMF Process Lead at key meetings
Support the Global TMF Process Lead in developing & implementing various TMF Process Initiatives to achieve quality and compliance.
Provides leadership, infrastructure, and subject matter expertise to the TMF organization
Prioritizes book of work for the TMF Study Leads and assign resources based on study portfolio changes
Grows and develops internal staff to strengthen the organization
Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for maintenance of compliant TMFs and identify efficiency opportunities
Assists and trains internal and CRO teams on TMF processes
Maintains continuous knowledge of the regulatory requirements and industry trends related to TMF compliance
Communicate as appropriate with relevant stakeholders
Along with Global TMF process Lead, leads and participates in continuous improvement initiatives related to clinical trial documentation and TMF compliance
Address gaps in TMF compliance as highlighted by Quality metrics and KPI
Minimum of a Bachelor degreein Science, Pharmacy, or related field
At least 5-7 years of experience in health sciences or related industry
Strong working knowledge of TMF, eTMF and clinical document management systems.
Strong organizational and technical ability. Demonstrated Excel, PowerPoint, and SharePoint skills.
Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.